Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
This study has been completed.
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01229462
First received: October 26, 2010
Last updated: August 15, 2012
Last verified: August 2012
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Purpose
This study will evaluate the safety and efficacy of brimonidine tartrate/timolol fixed combination (Combigan®) compared with brimonidine tartrate (Alphagan®) and timolol in patients with glaucoma or ocular hypertension who do not respond well to topical beta blockers.
| Condition | Intervention |
|---|---|
|
Glaucoma Ocular Hypertension |
Drug: brimonidine tartrate/timolol fixed combination ophthalmic solution Drug: brimonidine tartrate ophthalmic solution Drug: timolol ophthalmic solution Other: fixed combination vehicle |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Allergan:
Primary Outcome Measures:
- Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).
| Enrollment: | 238 |
| Study Start Date: | October 2010 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Combigan®
One drop of brimonidine tartrate/timolol combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
|
Drug: brimonidine tartrate/timolol fixed combination ophthalmic solution
One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Other Name: Combigan®
Other: fixed combination vehicle
Fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
|
|
Active Comparator: Alphagan® and Timolol Concurrent
One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
|
Drug: brimonidine tartrate ophthalmic solution
One drop of brimonidine tartrate ophthalmic solution (Alphagan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Other Name: Alphagan®
Drug: timolol ophthalmic solution
One drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Open-angle glaucoma or ocular hypertension in at least one eye that is not responsive to topical beta blockers
- No anticipated wearing of contact lenses during study
Exclusion Criteria:
- Active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye)
- Any intraocular surgery or laser (eg, cataract surgery or Lasik) within 3 months
- Required regular use of other ocular medications except for occasional use of artificial tears
Contacts and Locations More Information
No publications provided
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT01229462 History of Changes |
| Other Study ID Numbers: | 190342-035 |
| Study First Received: | October 26, 2010 |
| Results First Received: | August 15, 2012 |
| Last Updated: | August 15, 2012 |
| Health Authority: | China: State Food and Drug Administration P.R. China (SFDA) |
Additional relevant MeSH terms:
|
Glaucoma Hypertension Ocular Hypertension Eye Diseases Vascular Diseases Cardiovascular Diseases Timolol Brimonidine Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Antihypertensive Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists |
ClinicalTrials.gov processed this record on May 23, 2013